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Mod. VQ4122C Addendum to Medistim VeriQTM System User Manual VQ1990GB
VQ1991GB_rev. G
MEDISTIM VeriQ CTM SYSTEM USER MANUAL
© MEDISTIM 20142
© MEDISTIM 2014 3
CONTENTS1. INTRODUCTION 4
1.1 Acronyms,AbbreviationsandDefinitions . . . . . . . . . 4
2. INDICATIONS FOR USE 5
2.1 Indications for use statement . . . . . . . . . . . . . . . . . . . 5
2.1.1 Acoustic Power Reporting . . . . . . . . . . . . . . . . . . . . . . . .5
2.1.2 Guidance on the interpretation of TI and MI . . . . . . . . . .5
2.2 Warning statements . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.4 Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3. VeriQ C™ SYSTEM OVERVIEW 6
3.1 Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.2 Probe Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.3 Software Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
4. OPERATING THE VeriQ C™ 8
4.1 Required Personnel. . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4.2 Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4.2.1 Connecting the probe . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
4.2.2 Removing the Imaging Probe . . . . . . . . . . . . . . . . . . . . . .8
5. MEASUREMENT TYPES 9
5.1 Transittimeflowmeasurement(TTFM) . . . . . . . . . . . 9
5.1.1 Tasks during procedure by surgeon . . . . . . . . . . . . . . . . .9
5.1.2 Tasks during procedure by operator . . . . . . . . . . . . . . . .9
5.2 Pressure inputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.2.1 Calibrating the pressure transducer. . . . . . . . . . . . . . . . .9
5.3 Auxiliary inputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.3.1 Calibrating the AUX channel for ECG . . . . . . . . . . . . . . . .9
5.3.2 Calibrating the AUX channel for pressure . . . . . . . . . . .10
5.4 Imaging Measurements . . . . . . . . . . . . . . . . . . . . . . . 10
6. ULTRASOUND IMAGING 11
6.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
6.2 Selecting application . . . . . . . . . . . . . . . . . . . . . . . . . 11
6.2.1 Definingthevesselname . . . . . . . . . . . . . . . . . . . . . . . .11
6.2.2 Savecurrentconfiguration . . . . . . . . . . . . . . . . . . . . . . .11
6.3 Selecting mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6.3.1 Stop /Start. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
6.4 Imaging Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6.4.1 Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
6.5 Probe Orientation indicator . . . . . . . . . . . . . . . . . . . . 12
6.5.1 Image Flip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
6.6 Exposure and Ultrasound statistics . . . . . . . . . . . . . 13
6.6.1 Gray scale and color bar . . . . . . . . . . . . . . . . . . . . . . . .13
6.6.2 TGC (Time Gain Compensation) . . . . . . . . . . . . . . . . . .13
6.6.3 Combined . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
6.6.4 Miscellaneous Controls . . . . . . . . . . . . . . . . . . . . . . . . .13
6.7 Imaging Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
6.7.1 Probe Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
6.7.2 B-Mode properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
6.7.3 PW Doppler mode properties. . . . . . . . . . . . . . . . . . . . .14
6.7.4 ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
6.7.5 Depth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
6.8 2D Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
6.8.1 2D Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
6.8.2 Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
6.8.3 Persistence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
6.9 Color Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
6.9.1 Color Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
6.9.2 Colorflowmodeproperties . . . . . . . . . . . . . . . . . . . . . .15
6.9.3 Region of Interest (ROI) . . . . . . . . . . . . . . . . . . . . . . . . .15
6.9.4 Steering Angle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
6.9.5 Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
6.9.6 Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
6.9.7 Hide color . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
6.9.8 Color Flow tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
6.9.9 Velocity/Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
6.9.10 CFM Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
6.9.11 PRF and Flow Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
6.10 PWMode(Pulsed-waveDoppler) . . . . . . . . . . . . . . . 17
6.10.1 PW Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
6.10.2 PW Gate control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
6.10.3 Steering angle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
6.10.4 Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
6.10.5 Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
6.10.6 Velocity correction angle . . . . . . . . . . . . . . . . . . . . . . . .17
6.10.7 PW Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
6.10.8 2D Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
6.10.9 PRF and Flow rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
6.10.10 PW display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
6.11 Playback Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
6.12 Measurement and annotations . . . . . . . . . . . . . . . . . 18
6.12.1 Using the Annotations and Caliper tools . . . . . . . . . . . .18
6.12.2 Setting up custom tools . . . . . . . . . . . . . . . . . . . . . . . . .19
APPENDIX A. ACOUSTIC OUTPUT REPORT 20
A.1 Probe Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
A.1.1 EL100015 - L15 Ultrasound Imaging probe . . . . . . . . . .20
A.2 Safety guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
A.2.1 EL100015 - Acoustic Output - 2D mode . . . . . . . . . . . .20
A.2.2 EL100015 - Acoustic Output - Color Flow mode . . . . . .20
A.2.3 EL100015 - Acoustic Output - PW Doppler mode . . . . .20
APPENDIX B. DICOM FUNCTIONALITY 21
B.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
B.2 ConfiguringtheDICOMfunctionality . . . . . . . . . . . . 21
B.2.1 ConfiguringtheVeriQC™networksettings . . . . . . . . .21
B.2.2 ConfiguringaDICOMserver . . . . . . . . . . . . . . . . . . . . .21
B.2.3 Configuringthehospitalservers . . . . . . . . . . . . . . . . . .21
B.3 UsingtheDICOMfunctionality . . . . . . . . . . . . . . . . . 21
B.3.1 Importing patient data from a worklist server . . . . . . . .21
B.3.2 Exporting recorded data to a DICOM server . . . . . . . . 22
B.3.3 Export job queue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
B.4 Offlineuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
B.4.1 Worklist import . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
B.5 Icon description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
© MEDISTIM 20144
1. INTRODUCTION
MedistimVeriQ C™ User Manual is an addendum to the Me-distimVeriQ™SystemUserManual.
This User Manual is not intended as a stand-alone document. TheVeriQ™SystemUserManualmustbeconsultedinorderto obtain a complete user guidance.
This manual covers the ultrasound imaging functionality of theVeriQSystemmodelVQ4122C,labeledasVeriQ CTM.
Other information regarding the use and handling of the Me-distimVeriQ™ System its probes and accessories is covered intheVeriQUserManual.
1.1 Acronyms,AbbreviationsandDefinitions
Thetablebelowlistthemostcommonacronyms,abrevia-tionsanddefinitionsusedinthismanual:
Abbreviation Definitions
VeriQ C™ BrandnamefortheMedistimVeriQC™Sys-temmodelVQ4122C
VeriQ™ User Manual
VeriQ™SystemUserManual
TI Thermal Index
MI Mechanical Index
PW-Doppler Pulsed-Wave Doppler
TIS Thermal Index for Soft tissue
FR Frame Rate
2D Two-Dimensional
TGC Time Gain Compensation
PRF Pulse Repetition Frequency
ALIASING Refers to the frequency wrap around that occurs when a continuous time signal has fre-quencies larger than half of the sampling rate.
USB Universal Serial Bus
GUI Graphical User Interface
ACI Acoustical Contact Indicator or Acoustical Coupling Index
© MEDISTIM 2014 5
2. INDICATIONS FOR USE
2.1 Indications for use statement
TheMedistimVeriQC™Systemisintendedforuseasanintraoperative system utilizing ultrasonography to visualize bloodflowandtoguidesurgeonstosuccessfullyplanandaccomplish surgical interventions.
Theclinicalindicationsforthedeviceare:.
1. Accurate transit time blood volume and Doppler velocity flowmeasurementsduringcardiovascular-,vascular-andtransplantation-surgery.
2. Simultaneousmeasurementsofbloodpressure,vascularresistance,interfacedphysiologicalsignalsandotherderived parameters during these procedures.
3. Detection of normal and abnormal blood volume and Dopplervelocityflowpatternsduringtheseprocedures.
4. Provides guidance to prepare surgical plans at the initi-ation of surgery and to support the successful accom-plishment of surgery including detection and location of vessels during surgical procedures.
5. DetectionandquantificationofthedegreeofstenosisinarteriesbyusingtheDopplervelocityprofile.
2.1.1 Acoustic Power Reporting
FortheAcousticOutputReports,refertoAppendixA.
2.1.2 GuidanceontheinterpretationofTIandMI
The TI (Thermal Index) and MI (Mechanical Index) are two parameters that are always displayed on the screen during ultrasoundimaging,andgiveinformationaboutultrasonicexposure to the patient. This section provides guidance on how to interpret the parameters.
The MI gives a relative indication of the potential for mechani-calbioeffects,suchascavitation.
The TI gives a relative indication of the potential for tempera-tureincreasealongtheultrasoundbeam.FortheVeriQC™,Thermal Index for Soft Tissue (TIS) is displayed.
TheTISandMIindicesdonotprovidesafetylimits,buttheydo provide an indication of the conditions which are more likely than others to produce thermal and/or mechanical effects. See the following table for an overview of the relative importance of maintaining low exposure indices in various scanning situations.
Of greater Importance Of lesser importance
MI With contrast material
Cardiac scanning (lung expo-sure)
Abdominal scanning (bowel gas)
In the absence of gas bodies:i.e.inmosttissueimaging
TI First trimester scanningFoetal skull and spinePatient with fever
In any poorly perfused tissue
Ophthalmic scanning (requires different risk estimate)
If ribs or bone are exposed
Inwellperfusedtissue,i.e.liver,spleen
In cardiac scanning
In vascular scanning
2.2 Warning statements
This User Manual contains warnings and Notes according to thefollowingdefinitions:
Warning This warning will describe clinical contraindications and possible damage to the device if the recommended instruc-tions or recommendations are not followed. Please read and follow these warnings carefully. If Warnings are not taken into consideration, serious injury and damage to personnel, devices and the operating environment can occur. The man-ufacturer cannot be held liable for injury or damage if these precautions are disregarded.
NoteA Note contains important tips, recommendations and sup-plementary information intended to optimize the use of the system.
2.3 Contraindications
WarningThe Medistim VeriQ C™ System is not intended for use in the following surgical applications: • Fetal scanning• Ophthalmic scanning• Cranial / trans cranial scanning • Neonatal cephalic use
2.4 Consumables
RefertotheVeriQ™systemusermanual,VQ1990GB,foralist of necessary consumable items to perform an operation.
© MEDISTIM 20146
3. VeriQ C™ SYSTEM OVERVIEW
Soft power button
19”Touchscreenmonitor
2 USB connection ports
Mainpowersupplyswitch
EL probe connection port
Printer
Smart card entrance
© MEDISTIM 2014 7
3.1 Front Panel
The ultrasound imaging probe connector is labeled “Imaging Probe”.
TheMedistimDopplerprobecannotbeusedonVeriQC™,but Doppler measurement capability is provided by the 2D Imaging probe. Using the 2D Imaging probe for Doppler measurements allows simultaneous visualization of the PW gate position and the display of the PW Doppler spectrum.
TheimagingprobeconnectorislabeledasTypeCF,meaningthat the probe is suitable for direct cardiac contact.To the right of the imaging probe connector is the locking lever. It is in the locked position when the lever is up.
3.2 Probe Description
TheEL1000152DImagingProbeisspecificallydesignedforepicardiac imaging.
Theyhavealowprofile,allowingeasyaccesstodifficulttoreachareas,suchasthebacksideoftheheart.
Toinsuresafety,reliabilityandsterilizationefficacy,theEL100015 probe has been validated to withstand 100 ster-ilization cycles without the electrical patient isolation being compromisedorweakened.After100cycles,amanualelec-trical leakage current test is required for continued electrical safety.TheVeriQsystemsoftwarewillwarntheuserwhensuch tests are necessary.
See User Manual EL499002.
3.3 Software Version
The software version currently running on the system can be identifiedbyopeningtheSysteminformationpagelocatedonthe Advanced System Functionality page.
© MEDISTIM 20148
4. OPERATING THE VeriQ C™
4.1 Required Personnel
TosuccessfullyoperatetheVeriQ CTM,atleasttwopeoplearerequired. One controlling the ultrasound Imaging Probe inside thesterilefield,andtheotherhandlingthesystemcontrolsoutsideofthesterilefield.
The main tasks for the system operator are to prepare the systembeforeuse,adjustthesystemduringoperationandtosaveessentialfindingsinordertodocumenttheprocedure.
Duringtheprocedure,itisimportantforthesurgeonandoperator to maintain a good dialog to work effectively and get the best possible results.
4.2 Preparation
TheVeriQ CTM System should be placed close the operating table as the imaging probe cable has a maximum length of 3 meters. It should be placed where the surgeon has a clear view of the screen and the system operator has access to the touch screen controls.
If the screen surface becomes contaminated with gel or other fluids,thetouchscreenoperationcanbeaffectedandthescreen may have to be cleaned before normal function can be resumed.
Oncethesystemisproperlyplaced,plugitintothemainspower system and press the power button.
Seechapter5.4intheVeriQUserManualfordetailedinstruc-tions on how to start the system and enter patient data.
4.2.1 Connectingtheprobe
TheultrasoundImagingProbe,whichhasbeenpreviouslysterilized (see manual EL499002 - Cleaning disinfection and sterilization)shouldbeplacedinthesterilefield,whilethesystem connector should be plugged into the system con-nector on the front panel.
Toplugtheprobesconnectorintothesystem,firstensurethat the locking lever is in the unlocked (down) position. Withtheprobecabletotheleft,inserttheprobeconnectorinto the system connector and move the locking lever into the upright position.
WarningDo not force the lever into the locked position. Forcing the lever when the probe is not fully inserted will damage the system.
Allow a few seconds for the Imaging Probe to be initialized and recognized by the system after being plugged in.
Warning The EL100015 probe has been validated to withstand 100 sterilization cycles without the electrical patient isolation be-ing compromised or weakened. After 100 cycles, a manual electrical leakage current test is required for continued elec-trical safety. See User Manual EL499002.
4.2.2 RemovingtheImagingProbe
Warning Incorrect probe removal may damage the system connector
Toremovetheprobefromthesystem,firstpressthe”Stop”button if the system is scanning.
Push the locking lever down and pull the connector straight outfromthesystem,neveratanangleasthismaydamage the connector.
© MEDISTIM 2014 9
5. MEASUREMENT TYPES
The purpose of this chapter is to provide a detailed descrip-tion of the different measurements that can be performed usingtheMedistimVeriQC™System.
5.1 Transittimeflowmeasurement(TTFM)
5.1.1 Tasks during procedure by surgeon
The surgeon will judge the diameter of the vessels to be mea-sured and inform the operator which probe(s) to connect.Theoperatorneedstobeinformedofwhichtypeofconduit,connection,andtargetvesselthatisbeingmeasured.
Arterial conduits such as the internal mammary arteries have to be skeletonized for a length corresponding to the width of theprobe,approximately1cm.
WhentheTTFMprobeisplacedontoaconduit,thesystemwillgenerateasimulatedDopplersound,indicatingthatflowhasbeendetected.Thevolumeofthissoundisadjustable,using the on-screen buttons.
Toensureaccurateflowmeasurement,itisimportantthattheprobe is placed perpendicular to a straight segment of the measured vessel. All parts of the vessel should be inside the probeasshowninthefollowingfigure.
Recommended probe placement on straight vessel segments
5.1.2 Tasks during procedure by operator
Theoperatorshouldinformthesurgeonofthemeanflowrate,thepulsatilityindex(PI)andthediastolicfilling(DF).Assoonasastablemeasurementisreached,themeasurementshould be saved by pressing the Save button.
5.2 Pressure inputs
The pressure inputs allows connection pressure transducers for direct monitoring of the patient’s blood pressure. The Me-distimVeriQC™Systemcanbedeliveredwithtwopressureinputs,bothproviding5Vdrivingvoltageforthetransducers.Interface cables to common commercially available transduc-ers can be ordered from Medistim.
5.2.1 Calibratingthepressuretransducer
Afterconnectingapressuretransducer,thesystemallowsthesettingofzero-levelandfine-tuningofthegainforoptimalmeasurements. The procedure requires reference signals of 0 mmHg and 100 mmHg. Enter the calibration screen by pressing the Pressure properties button.
First apply 0 mmHg and press the zero-button. Wait until the curve stabilizes at zero. Then apply 100 mmHg and adjust the gain until the curve rests at 100 mmHg.
The calibration of the pressure channels are non-persistent and must be done for each new transducer.
5.3 Auxiliary inputs
The auxiliary inputs can be used to measure any external voltagesignalwithin±4V.Thesignalisfiltered,conditioned,assignedtoameasurementunitandincludedintheVeriQC™measurementset.Theavailablesignalrangesare±10mV,±100mV,±500mVand±4V.Theusercanselectsignallevel,measurementunit,filteringandsignalconditionfromtheAUXcalibration screen as described in the sections below.
WhenselectingmmHgasthemeasurementunit,thesys-tem treats the AUX input as a pressure input with respect to derived traces and calculations.
The AUX channel selected for ECG input will automatically display the heart rate in BPM and the systolic and diastolic phases can be drawn on the curve trace (user selectable).
Forothermeasurementunitsselected,thecurvetracewillsimply show the measured value in terms of the selected unit.
5.3.1 CalibratingtheAUXchannelforECG
Turn on the system and connect the ECG cable to the anesthesia monitoring system. For the purpose of calibra-tion,anECGsimulatorcanbeusedwiththemonitoringsystem.SelecttheLivesessionscreen,andtheAuxiliarycurvewindowwillappear.Dependingonsignalstrength,theECG waveform will be visible. If the scale and measuring unit appearcorrect,nofurtheradjustmentsarenecessary.
Toimprovethesettingsforoptimaldisplay,presstheECGproperties button and the Calibrating ECG window will ap-pear.
Afterselectingthecorrectmeasuringunit,ECG,selectan input factor that corresponds to the signal input. If the displayedsignalhasalowamplitude,thenselectasmallerinput range. Note the AD range displayed in the upper right-handcornerofthecurvewindow,asitisimportantthattheADrangeislessthenthesaturationlevelof100%.Forfineadjustmentswithintheselectedrange,usetheScalingupand down buttons.
WhenthecorrectECGcurveisdisplayed,thesettingsshouldbe saved by pressing the Save button. To ensure that the newsetupisusedwhenevertheECGisconnected,presstheSet current as default button.
© MEDISTIM 201410
Note When using the Medistim VeriQ C™ System with more than one monitoring system that requires independent adjust-ments, different calibration settings can be saved under a profile name, such as OT 1 and OT 2. The operator can choose the stored calibration each time the system is moved by entering the calibration menu and selecting the appropri-ate saved profile.
5.3.2 CalibratingtheAUXchannelforpressure
Turn on the system and insert the cable from the signal monitor.Forcalibration,asimulatorthatemitsknownsignalscanbeused.SelecttheLivesessionscreen,andtheauxiliarycurvewindowwillappear.Dependingonthesignalstrength,the monitored curve may be visible straight away. To cali-bratethecurve,presstheAUX1/2propertiesbuttonandtheCalibrating AUX1/2 window will appear.
Inordertocalibratethecurveproperly,asignalwithtwoknownamplitudesisneeded.Oneoftheseistypicallyzero,the other can be chosen randomly as long as it is feasible and known.
First,selectthecorrectmeasuringunit.(Forpressure,itwould be mmHg.) Then select an input range that corre-spondstothephysicalsignal.Ifthesignalhaslowamplitude,select a smaller input range.
It is important that the AD range displayed in the upper part of the curve window is less than the saturation level of 100%. Whenthesignalfromthemonitorissettozero,presstheZero button on the lower right side of the curve view to set the zero signal level. Change to the signal value with known amplitude and use the scale up and scale down buttons to adjustthedisplayedvaluesothatitfitstheinput.Readjustthe input range if necessary.
Whenthecalibrationissatisfactory,assigntheprofileanap-propriatenameintheCurrentprofileeditboxandpressSave.
Tosettheactiveprofileasdefaultforthechannel,presstheSet current as default button on the lower left part of the screen.
For all types of AUX measurements the calibration process is exactly the same. Exchange the unit to suit the measured variable. Adjust input range and gain so that the signal is within saturation limits and correct for two known values.
5.4 Imaging Measurements
Proceed to chapter 6 for detailed information on how to per-form imaging measurements.
© MEDISTIM 2014 11
6. ULTRASOUND IMAGING
6.1 General
TheMedistimVeriQC™Systemusesultrasoundbeamstocreate a detailed and real-time picture of the tissue. Ultra-sound beams are transmitted into the tissue and the intensity of the returned echoes are displayed as variations in bright-ness.
Ultrasound scanning is very sensitive to the coupling be-tween the probe face and the tissue. Any air gaps will cause ineffective coupling which can result in dark vertical shadow-ing or a complete loss of image.
Ifthesurfacetobescannedisrough,haspocketswhereaircanbetrappedorisnotmoistenough,sterileultrasoundcoupling gel could be used beteween the tissue and the transducer.
Theimagecanbeoptimizedinzonesasafunctionofdepth,called focal zones. Focal zones should be selected in the area of most interest. Up to four focal zones can be used simultaneously.Atdeeperdepths,usingmultiplefocalzonescan cause the scanner to operate at a slower frame rate. In ColorandPW,onlyonefocalzoneisusedandiscontrolledbythelocationoftheRegionofInterest(ROI),orgateposi-tion.
The image brightness should be approximately uniform with depth.Ifitisnot,adjusttheTimeGainCompensation(TGC)controls.
Iftheoverallbrightnessneedstobeincreasedordecreased,use the 2D gain control.
Tostartimaging,presstheImagingtab.
TheMedistimVeriQC™Systemwillbeginscanningusingthe default application settings. An ultrasound image will be displayed as soon as the transducer is placed on tissue.
6.2 Selecting application
TomaketheoperationoftheMedistimVeriQ C™Systemassimpleaspossible,variousapplicationsareavailable.Eachapplication presets the system parameters for a particular situation.Forexample,thetypicalcontrolsettingsforscan-ning the aorta are different from those used to scan coronary arteries.
The Application button brings up a menu for the selection of different Applications. Each application has preset system settingsthatareoptimalforscanningspecificanatomicalstructures.
For example the Aortic application changes to a deep depth andfocalzonestoimagedeepvesselwalls,whiletheCor-onary application sets the depth and focal zones to scan at very shallow depths.
Inaddition,customsettingscanbesavedbytheuser.Thename,orderandvisibilityoftheapplicationsareconfigurablein the System Settings.
6.2.1 Definingthevesselname
Refertosection5.4.7intheVeriQ™UserManual,VQ1990GB.
6.2.2 Savecurrentconfiguration
WhentheSavecurrentconfigurationbuttonispressed,amenu is brought up that allows entering an application name. Theconfigurationmaybesavedusinganexistingapplicationname,aslongastheexistingapplicationisnotoneofthestandard applications provided by Medistim.
6.2.2.1 Cancel
The Cancel button exits this menu without creating/updating the application.
6.2.2.2 OK
The OK button exits this menu and stores the current imaging configurationusingthespecifiedapplicationname.Notethattheapplicationwillstorethesettingsforallmodes(2D,Colorand PW).
6.2.2.3 Volume
The Volume controls set the application volume including the PWaudio.Pressthecontrolanddragyourfingertosetthedesired level.
© MEDISTIM 201412
6.3 Selecting mode
Whileimaging,theVeriQ C™hasthreebasicmodes:2D,Color and PW.
Mode Description
2D : Basic 2D gray scale image of the tissue
Color: 2Dimagepluscolorflowshowingbloodflowineither Velocity or Power mode displays
PW: 2D gray scale image with PW spectral display of bloodflow
Tochangetoadifferentmode,pressthecorrespondingmode tab.
6.3.1 Stop /Start
Tostopscanningandfreezetheimage,presstheStopbut-ton. The Stop button will then change to the Start button. To startscanningagain,presstheStartbutton.
When the user interface has not been used for a period of 5 minutes the system will stop imaging and freeze the image automatically. This prevents excessive heat from building up in the probe while it is in free air and not being used.
6.4 Imaging Screen
6.4.1 Layout
# Screen Element RelevantChapter
1 Probe Orientation
2 Exposure Statistics
3 GrayScaleMap(colorflowmap)
4 TGC
5 ModeTab:2D
5 ModeTab:Color
5 ModeTab:PW
6 Lateral Scale
7 Depth Control
8 Depth Scale
9 ECG Display
10 Imaging Properties
11 Vessel Name
12 Application
13 Volume
14 ECG Properties
15 Miscellaneous Controls
16 Focal points
6.5 Probe Orientation indicator
Inthetopcorneroneithersideofthe2Ddisplay,adotwillbe visible. The probe will also have a dot on one end of the transducer to indicate how the image is oriented with respect totheprobe.Iftheprobedoesnothaveadot,thentheendof the transducer where the cable exits will correspond to the dot.
© MEDISTIM 2014 13
6.5.1 Image Flip
To accomodate different scanning situations the image can beflippedleft/right.Presstheprobeorientationmarkertoflipthe image
Flippingtheimageenablesamirroringofthescanning,theprobe movements will correspond to the on screen move-ments for a more intuitive user experience.
Tofliptheimage,presstheprobeorientationmarkerinthetop left or right of the image.
6.6 Exposure and Ultrasound statistics
This system conforms to the 60601-2-37 standard for report-ing acoustic power output. It is the responsibility of the user to monitor these indices and insure safe exposure levels forthespecificapplicationbeingperformed.(Seesection2.2.1 Acoustic Power Reporting and 2.2.2 Guidance on the interpretation of TI and MI.)
Abbreviation Description
f: Operating frequency (maximum transmit frequen-cy / Doppler frequency)
TIS: Thermal Index for Soft Tissue*
MI: Mechanical Index*
FR: Frame rate (number of times the 2D image is updated each second)
NoteOnly shown during live imaging (not shown during playback)
6.6.1 Gray scale and color bar
The grey scale bar indicates how the intensity of the received signal is mapped into the display brightness. When in Color Mode,themapchangestotheColorFlowMap,indicatinghow velocity or power is mapped to color.
Note that the velocities shown on the color map during ve-locity mode are without Doppler angle correction. Use PW to obtain velocities with Doppler angle correction.
6.6.2 TGC(TimeGainCompensation)
Press the TGC icon to get access to the TGC slider controls.
Each slider controls the imaging gain at the corresponding depth.
Toadjust,presstheslideranddragthecontroltothedesiredsetting. Press the TGC icon again to hide the TGC sliders.
6.6.3 Combined
PressingtheCombinedbuttonaddsorremovesFlow*,Pres-sure*,andAux*graphstothe2DimageandECGgraph.
Note: *graphs will only be shown if there are corresponding probes connected.
6.6.4 Miscellaneous Controls
ThefollowingcontrolsaredescribedinthebasicVeriQUserManual:
1. Save2. Stop/Start3. Derived Setup*4. Calculate*5. Comment
Note: * Indicates controls that are available only when Advanced Mode has been selected under System Settings.
6.7 Imaging Properties
Pressing the Imaging Properties button displays a table of information concerning the probe and current operating con-ditions. The report can also be printed.
6.7.1 Probe Information
Item Description
Probe: Name of the current probe model
Usage: Number of times this probe has been used
S/N: Serial number of the current probe
FirstUsed: Datethatthisprobewasfirstused
6.7.2 B-Modeproperties
B-Modeproperties
FrameRate: How often the image is updated (in frames per second)
© MEDISTIM 201414
B-Modeproperties
Numberofbeams: Number of 2D ultrasound beams that make up an image (relates to lateral resolution and frame rate)
Depth:
Maximum depth currently displayed
Frequen-cy:
Operating frequency (highest receive fre-quency may be different than the transducer center frequency)
Focal Points:
Available focal points. Select /deselect the desired focal points by pressing the box
6.7.3 PW Doppler mode properties
PW Doppler mode Description
FrameRate: How often the image is updated (in frames per second)
Frequency Doppler operating frequency
PRF: Pulse Repetition Frequency for Doppler
Gatedepth: Depth for the center of the Doppler gate
Gatesize: Width of the Doppler gate
6.7.4 ECG
See chapter “4.6.1 Calibrating the AUX channel for ECG” in theVeriQ™UserManual.
WhennoECGisconnectedtothesystemaflatECGsignalwill be displayed and the ECG probe-button will be labeled “Virtual ECG”. The virtual ECG is used to provide a timeline when viewing stored data. When an actual ECG signal is present it can be used for contextual navigation in the mea-surement.
6.7.5 Depth
Press the Depth icons to increase or decrease the maximum depth of the display. Deeper depths may have slower update rates (frame rates) so it is best to use shallower depths when possible.
6.8 2D Mode
The 2D Mode displays a grayscale image with no Color or PW. To get the best possible 2D image use this mode. When usingothermodes,trade-offsaresometimesmadetoim-proveotherperformanceparameters,suchasframerate.
6.8.1 2D Tab
Pressing the 2D tab will change the imaging mode to 2D (grayscaleonly).Ifthesystemwasalreadyin2D,thenamenu appears with more advanced controls for optimizing the 2D image.
6.8.2 Gain
Use the Gain control to increase or decrease the overall brightness of the image.
Ifadjustedtoohigh,thebrighterechoesmaysaturateandlossofhighleveldetailcanresult.Withhighgain,overallnoisemayincrease.Ifadjustedtoolow,lowlevelechoesmaynotbevisible,andthedepthofpenetrationwillbeless.
6.8.3 Persistence
Itispossibletofiltersomeofthenoiseintheimagebyusingadditional persistence.
Persistenceusesatimeaveragingtechniquetoreducenoise,but this will also blur any tissue that is moving too fast for the persistence selected.
© MEDISTIM 2014 15
6.9 Color Mode
InColorMode,thesystemdisplaysa2Dgrayscaleimagewithanoverlayofcolorthatrepresentsthebloodflowintheregion of interest.
6.9.1 Color Tab
Pressing the Color tab will change the operating mode to Color. If the system was already in Color Mode then a menu will appear allowing access to additional Color controls.
6.9.2 Colorflowmodeproperties
Colorflowproperties
FrameRate: How often the image is updated (in frames per second)
Number of Beams:
Number of Color ultrasound beams that make up the image (relates to lateral resolution and frame rate)
LVR: Low Velocity Reject (velocities below this are attenuated by the system)
Frequency Ultrasound frequency used for Color
PRF: Pulse Repetition Frequency (relates to the maxi-mumvelocitythatcanbedisplayed,determinesaliasing frequency)
Focus: Current focal point (calculated by system based on ROI position and size)
Hide Flow Same function as described in section 6.9.7 - Hide Color
6.9.3 RegionofInterest(ROI)
The ROI is the area of the image that the system is analyzing forbloodflow.AwideROIwilloftenslowtheframeratedown. Narrowing the ROI will often increase the frame rate. 6.9.4 Steering Angle
Press and drag the steering icon to the desired angle.
6.9.5 Position
Press the center of the ROI and drag the ROI to the desired position.
6.9.6 Size
Press the lower right hand corner of the ROI to change the size of the ROI. Increasing the width of the ROI may slow the frame rate.
6.9.7 Hide color
Press this control to quickly turn the displayed colors on or off. This is useful if it is necessary to look at a 2D feature that is obscured by the color. Note that this 2D image will not havethespatialresolutionofthe2Dmodeonly,sinceitisusing one focal zone and high frame rate settings.
1 Region of Interest (ROI)
2 Steering Angle
3 Size
4 Velocity scale control
6.9.8 Color Flow tips
Color Flow operates on the same Doppler principles as PW-Doppler.
Thesystemcanonlymeasurethecomponentoftheflowthatistowardsorawayfromthetransducer,alongtheultrasoundbeam.Iftheflowisparalleltothefaceofthetransducer,thentheangleoftheROImustbesteered,inordertohaveacom-ponentoftheflowalongtheultrasoundbeam.
Highflowratesrequirehighpulserepetitionfrequencies(PRF)toavoidaliasingeffects.JustasinPW,thiscancauselowvelocitiestobeattenuatedbythewallfilter.LowPRF’schangethevelocityscalesothatlowflowsaremoreeasilyseen,buthighflowswillalias(appearingashighflowsintheopposite direction) and tissue motion that is sometimes inter-pretedasflow(flash).Oftenwhensearchingforalowvelocityvessel (typically a vein) it is best to use a low PRF until it is found and then adjust the PRF to avoid aliasing.
© MEDISTIM 201416
WheninColormode,thesystemwillautomaticallyswitchtoa single focal zone and High Frame Rate. While this sac-rificessome2Dimagequality,itisimportanttomakethistrade-off to achieve reasonable Color frame rates. While in Color,thesystemwilladjustthefocalzonetotracktheROIposition.
6.9.9 Velocity/Power
Color Flow can operate in either Velocity Mode or Power Mode.
VelocityModewillcalculatethemeanvelocityoftheflowanddisplay a color that represents the magnitude and direction offlow.Redindicatesflowtowardsthetransducer,whileblueisflowawayfromthetransducer.
WarningIf the flow is aliased, both the direction and velocity can be displayed incorrectly!
NoteVelocities displayed during color flow are not corrected for Doppler angle. Power mode mode should be used to obtain velocities that have been corrected for Doppler angle.
InPowermode,thesystemcalculatesthepowerreturnedfromtheflowechofordisplay.Nodirectioninformationisavailable in Power mode.
The following two images illustrate how the color changes dependentonangleinvelocitymode,andthethirdshowshow it is independent of angle in power mode.
’Inpowermode,thecolorisindependentofangleasseeninpicture below.
6.9.10 CFM Gain
IftheColorsensitivityneedstobeincreased,usetheCFMGain.Ifthegainisincreasedtoofar,falsecolorechoeswillbe displayed in areas that should be tissue or in voids where no color should be present. Operator experience is often necessary to distinguish between false color and real color from blood.
6.9.11 PRF and Flow Rates
SelectthedesiredPRFbasedonflowratesexpected.UseahigherPRFforhigherflow,atthecostoflossoflowflowde-tail.UsealowerPRFforlowflowsattheexpenseofaliasinghighflowsandincreasedflash(interpretationof tissuemotionasflow).
Invelocitymode,thevelocityscaleonthecolormapwillchange according to the selected PRF.
Use the scale buttons to select the best scale according toexpectedflowrates.TheDopplerPRFwillbechangedaccordingly,theactualPRFcanbeviewedinthepropertiesscreen.
© MEDISTIM 2014 17
6.10 PWMode(Pulsed-waveDoppler)
6.10.1 PW Tab
Pressing the PW tab will change the operating mode to PW. If the system was already in PW Mode then a menu will ap-pear allowing access to additional PW controls.
InPWmode,thesystemdisplaysa2DgrayscaleimagewithagraphicalrepresentationofthePWgate.SeetheVeriQ™UserManual,Section5,foradditionalinformationonthePWdisplay.
1 PW gate
2 Gate position
3 Gate size
4 Velocity correction angle
5 Velocity scale
6 Invert spectrum
6.10.2 PW Gate control
The PW gate shows the ultrasound beam position and the depth that are used to collect data for the Doppler analysis. Making the gate smaller will provide narrower bandwidth spectrums,withsomelossinsensitivity.
Usingalargegate,makesiteasiertofindvessels,butspec-trumswillbebroad,sincevelocitiesacrosstheentirevesselare being sampled.
6.10.3 Steering angle
The ultrasound beam must always be angled towards the flowdirection.
The Doppler Angle should always be kept as small as possi-ble.At90degreestotheflow,noflowwillbedetected.Theuser must adjust both the orientation of the probe and the Dopplerangletogetthebestflowdata.
The system will always select the optimal steering angle based on the PW-gate placement and Velocity correction angle combination.
6.10.4 Position
Toadjustthegateposition,pressthePositioniconanddragthe gate to the desired position.
6.10.5 Size
Press and drag either size icon to achieve the desired gate size.
6.10.6 Velocity correction angle
Press and drag the Velocity correction angle icon to align the linesothatitisparalleltotheflow.
The Doppler principle can only measure the component of theflowvectoralongtheultrasoundbeam.Acorrectionfortheflowdirectionmustbemadeinordertodisplaytheactualflowvelocityinthevessel.
When the Velocity correction angle line is aligned parallel to theflow,thesystemwillautomaticallycorrectthedisplayedvelocity.
6.10.7 PW Gain
PW gain is used for increasing the gain level for the display ofthePWDopplerspectrum.IftheGainisadjustedtoohigh,the signal will saturate and cause signal noise to become more dominant.
6.10.8 2D Gain
The 2D Gain control allows the 2D gray scale image gain to be adjusted without returning to the 2D mode. Press the controlanddragit,toadjustthegain.
6.10.9 PRF and Flow rates
HighflowratesrequirehighDopplerPRF’s(PulseRepetitionFrequency) in order to acquire data without aliasing. Low PRF’sshouldbeusedwhenanalyzinglowflowrates.
© MEDISTIM 201418
IftoohighaPRFisusedthenlowflowcomponentsofthespectrum will be at the extreme low end of the frequency scaleandpossiblyattenuatedbythewallfilter.IftoolowaPRFisused,highflowsignalswillaliasandwraparoundthespectrum(ahighflowsignalwillappearasflowintheoppo-site direction).
SettheflowrateorPRFbyusingthescalebuttonsinthespectrum display as for other curves. The Doppler PRF will bechangedaccordingly,theactualPRFcanbeviewedintheproperties screen.
6.10.10 PW display
RefertotheVeriQ™UserManualchapter5.6“Tasksduringprocedurebyoperator”,forinformationregardingthePWspectral display and controls to optimize it.
The timescale of the PW measurement is by default 5 sec-ondslikealltheothercurvemeasurementsintheVeriQ.
Tochangethis,firstenterstoppedmodebypressingthestopbutton. Then the zoom controls appear in the top right corner. These can be used to either shorten or lengthen the times-caleonthecurrentlystoppedmeasurement,andthesettingsare kept when returning to live.
6.11 Playback Mode
In Stopped- and Edit-Mode it is possible to playback the most recent data.
Whenpressingtheplay-button(2),thedatabetweenthecursors is looped and an indicator shows the current play-back position. The arrows (1) on the left and right side of the playback button steps respectively one image back or forth in the data. The playback speed control (3) on the right side hasfourdifferentspeedsettings.Normalspeed,halfspeed,1/4-speed and 1/8-speed.
When a real ECG signal with heart-cycle information is pres-ent the loop-length control (4) can be used to automatically extend,orshorten,theplaybackloopbyonecardiaccycle.If the signal does not have phase information or no signal is present(VirtualECG),thelooplengthcontrolsimplydoublesthe distance between the cursors.
The skip controls (5) let the user skip back or forth one heart-cycle in the collected data as long as the signal has val-id phase information. If the signal does not have valid phase information the controls move the cursors a distance equal to the distance between them.
ThesecontrolsaredescribedintheVeriQ™SystemUserManual. Note that the Zoom In and Zoom Out buttons refer only to the time scale and do not affect the size of the 2D image.
Controls available in stopped mode
1 Zoom in
2 Zoom out
3 Save
4 Start
5 Derived Setup*
6 Calculate*
7 Comment
8 Screen Capture*
9 Playback
Note: * Indicates controls that are available only when Advanced Mode has been selected under System Settings.
There are also additional controls available for limiting the rangeoftheplaybackloop.RefertotheVeriQ™UserManualfor further information.
6.12 Measurement and annotations
The measurement and annotation functionality allows the user to further analyze and add context to the ultrasound images acquired.
6.12.1 UsingtheAnnotationsandCalipertools
Measurement and annotation functionality is only available in Stopped Mode.
To select function and start measuring or annotating the image,pushtheiconleftoftheprobebutton.
© MEDISTIM 2014 19
This will replace the probe button with the measure and an-notation button. By pressing this once the currently selected toolisenabled.Bypressingtwice,the“Selecttool”dialogueis shown. A list of the available tools is shown and the user can select which one to use.
The “Annotation” tool allows the user to add and place text on the image. After an annotation is placed it can be selected and edited or moved at will.
Distance measures are done with the “Caliper” tool. After se-lectingthetool,pressandholdthepointontheimagewherethemeasurementshouldstart,thendragtotheendpointandrelease. The caliper can be resized and positioned afterwards if necessary.
6.12.2 Setting up custom tools
CustomtoolscanbeconfiguredbyenteringtheMeasure-mentsandannotationsconfigurationpage.Tofindthispage,goto“Systemsettings”,“AdvancedSystemFunctionality”and push the “Measurements / Annotations” button.
Before adding any custom tools only the default annotation and caliper tools will be present in this list.Toaddnewtools,pressthe“Add”button.
Thiswillbringupthe“Addconfiguration”dialogue.Heretheusercanconfigurecustomtoolstobettersuittheirspecificneeds. After adding new tools these will be visible in the tools menu in the measurement screen.
© MEDISTIM 201420
APPEnDIX A. ACOUSTIC OUTPUT REPORT
A.1 Probe Description
A.1.1 EL100015-L15UltrasoundImagingprobe
Type: Linear Array
WidthofImage: 15.2 mm
Frequency: 15 MHz
A.2 Safety guidelines
TheVeriQ C™isanintraoperativediagnosticsystemtobeused by surgeons during surgical interventions with 2D ultra-sound imaging that is intended for Epicardiac and Epiaortic scanning.
The relative importance of maintaining low exposure is considered “of less importance” both for TI and for MI. (see section2.1.2)However,oneshouldbeawareofthefactthatthe adverse biological effects of ultrasound on tissue appear to be threshold effects. When tissue is repeatedly exposed toultrasound,withintervalsinbetween,therewilllikelybeno cumulative biological effect. But if a certain threshold has beenpassed,biologicaleffectsmayoccur.
Recommendationsforuse:
• In general it is recommended to start examination with lowestpossiblesettingsforTIandMI,andmodifyfromthisleveluntilasatisfactoryimage,orDopplersignal,isobtained,keepingtrackofTIandMI.However,thepowerlevelsaresetbytheVeriQC™basedontheoperating mode and focal zone settings. The operator must monitor the TI and MI indices and assure that they are appropriate for the tissue being exposed.
• Minimize the exposure by keeping the exposure time as short as possible.
Note : The maximum probe face temperature for the L15 Ultrasound Imaging Probe EL100015 is 43°C.
A.2.1 EL100015-AcousticOutput-2Dmode
Acoustic output reporting for
Sound Technology Inc. transducer E
L100015
Docum
ent No. T
D-M
M-13001
Ver. 1.1
TD
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_13001_STI_E
L100015.docx
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EN
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S June 6
th, 2013 8 of 11
Output R
eporting Tables Table 3: G
lobal maxim
um M
I and TI values for the 2D - IN
VA
SIVE application of the STI EL100015
transducer (format: A
coustic Output R
eporting Table 201.103, IEC 60601-2-37:2007).
TIC
1.22
13.4
14.6
4.0
1.5
1.5
5.9
65
2
13.9
TIB
non-scanning
-
-
-
-
-
-
-
-
-
-
-
-
-
TIS
non-scanning
Aaprt>1cm2
-
-
-
-
-
-
-
-
-
-
-
-
-
-
Aaprt≤1cm2
-
-
-
-
-
-
-
-
-
-
-
-
scannning
0.96
15.2
14.0
10.0
1.5
1.8
18.0
48
2
11.4
MI
1.64
6.2
3.6
14.6
0.09
17929
7.5
2013
1.2
3.9
46
2
13.9
Index label
Maximum index value
[MPa]
[mW]
[mW]
[mm]
[mm]
[mm]
[mm]
[mm]
[MHz]
X [mm]
Y [mm]
[µs]
[Hz]
[MPa]
[mm]
[W/cm2]
FLx [mm]
FLy [mm]
[]
[mm]
[Vpp]
[]
[MHz]
pr.3
P
min[(P.3(zs), Ita.3(zs)]
zs
zbp
zb
z at max[Ipi.3]
deq(zb)
fawf
dim. of Aaprt
td
prr
pr at max[Ipi]
deq at max[Ipi]
Ipa.3 at max[MI]
focal length
F-number
focal depth
drive voltage
half cycles
transmit frequency
Associated acoustic parameters
Other information
Operating control conditions
A.2.2 EL100015-AcousticOutput-ColorFlowmode
Acoustic output reporting for
Sound Technology Inc. transducer E
L100015
Docum
ent No. T
D-M
M-13001
Ver. 1.1
TD
_MM
_13001_STI_E
L100015.docx
CO
NFID
EN
TIA
L
A
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EC
H ultrasound A
S June 6
th, 2013 9 of 11
Table 4: Global m
aximum
MI and TI values for the CFM
- INV
ASIV
E application of the STI EL100015 transducer (form
at: Acoustic O
utput Reporting Table 201.103, IEC
60601-2-37:2007).
TIC
2.60
14.8
12.5
1.1
1.5
1.0
1.1
60
10
12.5
TIB
non-scanning
-
-
-
-
-
-
-
-
-
-
-
-
-
TIS
non-scanning
Aaprt>1cm2
-
-
-
-
-
-
-
-
-
-
-
-
-
-
Aaprt≤1cm2
-
-
-
-
-
-
-
-
-
-
-
-
scannning
0.86
15.5
12.5
10.1
1.5
1.8
18.0
14
30
12.5
MI
1.63
5.9
3.6
12.7
0.26
12064
6.9
2319
1.3
4.3
38
8
12.5
Index label
Maximum index value
[MPa]
[mW]
[mW]
[mm]
[mm]
[mm]
[mm]
[mm]
[MHz]
X [mm]
Y [mm]
[µs]
[Hz]
[MPa]
[mm]
[W/cm2]
FLx [mm]
FLy [mm]
[]
[mm]
[Vpp]
[]
[MHz]
pr.3
P
min[(P.3(zs), Ita.3(zs)]
zs
zbp
zb
z at max[Ipi.3]
deq(zb)
fawf
dim. of Aaprt
td
prr
pr at max[Ipi]
deq at max[Ipi]
Ipa.3 at max[MI]
focal length
F-number
focal depth
drive voltage
half cycles
transmit frequency
Associated acoustic parameters
Other information
Operating control conditions
A.2.3 EL100015-AcousticOutput-PWDopplermode
Acoustic output reporting for
Sound Technology Inc. transducer E
L100015
Docum
ent No. T
D-M
M-13001
Ver. 1.1
TD
_MM
_13001_STI_E
L100015.docx
CO
NFID
EN
TIA
L
A
UR
OT
EC
H ultrasound A
S June 6
th, 2013 10 of 11
Table 5: Global m
aximum
MI and TI values for the PW
- INV
ASIV
E application of the STI EL100015 transducer (form
at: Acoustic O
utput Reporting Table 201.103, IEC
60601-2-37:2007).
TIC
0.77
10.3
12.5
6
1.5
1.7
10.3
60
30
12.5
TIB
non-scanning
1.00
10.3
9.9
1.0
12.5
6
1.5
1.0
1.7
10.3
60
30
12.5
TIS
non-scanning
Aaprt>1cm2
-
-
-
-
-
-
-
-
-
-
-
-
-
-
Aaprt≤1cm2
0.73
12.3
12.5
10.1
1.5
-
-
1.8
18.0
25
30
12.5
scannning
-
-
-
-
-
-
-
-
-
-
MI
1.63
5.8
3.4
12.6
0.60
283
6.7
1961
1.2
3.9
36
16
12.5
Index label
Maximum index value
[MPa]
[mW]
[mW]
[mm]
[mm]
[mm]
[mm]
[mm]
[MHz]
X [mm]
Y [mm]
[µs]
[Hz]
[MPa]
[mm]
[W/cm2]
FLx [mm]
FLy [mm]
[]
[mm]
[Vpp]
[]
[MHz]
pr.3
P
min[(P.3(zs), Ita.3(zs)]
zs
zbp
zb
z at max[Ipi.3]
deq(zb)
fawf
dim. of Aaprt
td
prr
pr at max[Ipi]
deq at max[Ipi]
Ipa.3 at max[MI]
focal length
F-number
focal depth
drive volatge
half cycles
transmit frequency
Associated acoustic parameters
Other information
Operating control conditions
© MEDISTIM 2014 21
APPEnDIX B. DICOM FUNCTIONALITY
B.1 Introduction
Systems with the optional DICOM functionality have the possibility to receive patient and study information from a network worklist server and export the acquired measure-ment sets for storage on a network storage server / Picture Archiving and Communication System (PACS)
InordertoutilizethefullDICOMfunctionality,thedepartmentmusthaveaworkingEthernetconfigurationwithaDICOMworklist server and a DICOM storage server / PACS . In addi-tion,theVeriQC™SystemneedsaccesstoanEthernetjackin order to connect to the network
B.2 ConfiguringtheDICOMfunctionality
BeforetheVeriQC™SystemcanbeconnectedtoaDICOMstorageorworklistserver,thelocalnetworkconnectionandtheremoteserversmustbeconfigured.
B.2.1 ConfiguringtheVeriQC™networksettings
Beforeinitiatingtheconfiguration,ensurethatthenetworkcable is connected and that the network icon on top of the screen indicates a valid connection. See section B.5 - Icon description.
StarttheVeriQC™SystemandopentheSystemSettingsscreen. Press the Advanced System Functionality button and then press the Network Settings button to open the Network settingspage.Here,theVeriQC™Systemnetworkcon-nectionisconfiguredusingparametersobtainedfromthehospital IT department. Enter the addresses and values obtained from the hospital IT departmentintheircorrespondingfields.IfthehospitalusesDHCP,selecttheUseDHCPbuttoninsteadofconfiguringthenetwork settings manually.
Network settings pageB.2.2 ConfiguringaDICOMserver
ToconfiguretheDICOMserver,navigatetotheNetworkset-tings page and press the Add button. This will bring up the DICOMserverconfigurationpage.
Entertheappropriatevaluesinthecorrespondingfields,andchoose how the server should be managed. After entering the server’s IP address the TCP/IP communication can be tested by pressing the Ping button. This will perform a ping commandtothespecifiedaddress,andtheresultwillbedisplayed on screen. IntheServertypedropdownmenu,specifywhethertheserv-er is a DICOM storage server or a DICOM Modality Worklist server.Whenservertypehasbeenselected,thescreenwillchangeinaccordancetotheservertype.Theconfigurationpage for the worklist server contains less parameters to set upthattheconfigurationpageforthestorageserver. Afterenteringtheserver’sIP-addressandDICOMconfigura-tion,theDICOMcommunicationcanbetestedbypressingthe Verify button. This will perform a DICOM C-ECHO request thatteststhattheserverandtheMedistimVeriQC™Systemareconfiguredinawaythatallowsthemtocommunicate.The result of the Verify operation will be displayed on screen.
Server configuration page
B.2.3 Configuringthehospitalservers
TheVeriQC™SystemmustbeaddedasanApplicationEntity (AE) on the servers that it is will communicate with. The processfordoingthiswillbedifferentfromservertoserver,so there will be no detailed guide for doing this in this manu-al. Consult the applicable server manual for more information. Alternatively,assistancefromthehospitalDICOMmanagercould be requested.
B.3 UsingtheDICOMfunctionality
B.3.1 Importing patient data from a worklist server
IftheVeriQC™SystemisconfiguredwithaDICOMconnec-tionandaWorklistserverhasbeensetup,thepatientinfor-mation can be directly imported instead of entered manually.
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New patient screen
Pressing the Worklist button in the New patient screen will perform a worklist request towards the selected worklist serv-er. The result of this request is a list of procedures scheduled fortheVeriQC™SystemandisdisplayedintheWorklistResult screen.
Patient information retrieved in this operation is automatically added to the database and upon selecting the desired pro-cedure;theinformationisenteredintheappropriatefieldsinthe patient screen. Press OK to proceed to the Live Session screen.
Worklist result screen
B.3.2 Exporting recorded data to a DICOM server
OnsystemswiththeDICOMinterface,therecordeddatacan be exported to the hospital’s DICOM storage servers. Thisisdonethesamewayasexportingtoexternalmemory,byfirstselectingthewantedmeasurementsandthenpress-ing the DICOM Export button. Exporting measurements to theservercanbequeuedasnormaleveniftheVeriQC™System is not connected to the network. All jobs will then beflaggedasPendinguntiltheVeriQC™Systemisrecon-nected to the network.
Alternatively,allpatientinformationincludingallmeasure-ments can be exported from the Search result screen. This is done by selecting the patient and pressing the Export button. This will bring up the Select Destination pop-up.
Select Destination
The Select Destination pop-up allows the user to select which server to export the measurements to. It also has the option to choose Local Drive – XML Export which is the conventional XML export (Not DICOM). After selecting the desiredserverandpressingExport,theVeriQC™SystemwillbegingeneratingDICOMfilestotransfer.
B.3.3 Export job queue
AftergeneratingDICOMfilesforexport,theprogressoftheexportjobcanbemonitoredintheDICOMJobQueuewindow. The job queue is accessed either by pressing the network icon to the right of the system settings tab or bypressingtheJobQueuebuttonintheSystemSettingsscreen.
Network Indicator Job queue
IntheJobQueuewindowisanoverviewofallpending,ac-tive,failedorrecentlycompletedtransferjobs.ThestatusofthejobisdisplayedintheStatuscolumn,andthenumberoftransferred elements can be seen in the Progress column.
More information about the individual transfer jobs can be viewedbyselectingthemintheSelectcolumn,andpressingthe Info button. This will bring up a window with additional information about the transfer or a detailed error message if the transfer has failed.
Transfer jobs can also be removed from the queue by select-ing the job(s) in question and pressing the remove button. Thejob(s)willthenbeflaggedasremovedandwillnotbetransferred to the server.
Job queue window
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A failed job can automatically be re-transferred a set number of times by selecting the Auto Resend button. The job will thenbeattemptedtransferredapredefinednumberoftimes.Whennomoreattemptsremain,thejobwillbeflaggedasFailed. The job can be re-transferred manually by pressing the Resend button.
Nexttimethesystemisrestarted,alljobsflaggedasCom-plete or Removed will be removed from the job queue.
B.4 Offlineuse
Intheeventthatthereisnoavailablenetworkconnection,much of the DICOM functionality can still be used.
B.4.1 Worklist import
IfitisnotpossibletohavetheVeriQC™connectedtothehospitalnetworkintheOR,theWorklistcanbepre-importedtotheVeriQC™System.
ConnecttheVeriQC™Systemtothenetworkatanappro-priatelocation,andpresstheWorklistbuttoninthepatientscreen. The worklist will be imported and the information will bestoredontheVeriQC™System.WhentheVeriQC™SystemisplacedintheOR,theworklistcanbeviewedbypressing the Worklist button as normal.
B.5 Icon description
Following is an overview of the job and network connection status icons related to the DICOM functionality. Some of the icons indicate the DICOM export status of measurements or completepatients,othersareusedtoindicatethestatusofthe network connection.
Job pending for transfer to server
Job transfer paused
Job transferring to server
Transfer complete waiting for commit response from server
Transfer complete and Commit message received from server
Transfer to server failed
Patient or case contains both exported and non-ex-ported measurement sets
Network not connected or present. (When acquiring connection,theiconwillalternatebetweenthisandthe icon for Network connection OK.
Network connection OK
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